LITHIUM CARBONATE FDA MedWatch Direct Reports Summary

These tables and charts are created from 392 voluntary U.S. reports for LITHIUM CARBONATE (LITHIUM CARBONATE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS LITHIUM CARBONATE Report.

Top Adverse Effects Associated with LITHIUM CARBONATE (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	TREMOR	40
2	TOXICITY TO VARIOUS AGENTS	39
3	DIZZINESS	25
4	NAUSEA	24
5	CONFUSIONAL STATE	22
6	DIARRHEA	21
7	ANXIETY	19
8	HEADACHE	18
9	SUICIDAL IDEATION	18
10	VOMITING	18
11	FALL	17
12	ACUTE KIDNEY INJURY	15
13	INSOMNIA	15
14	ANTIPSYCHOTIC DRUG LEVEL INCREASED	14
15	FATIGUE	14
16	GAIT DISTURBANCE	14
17	DEHYDRATION	13
18	AGITATION	12
19	BLOOD CREATININE INCREASED	12
20	DRUG INEFFECTIVE	12
21	LACK OF STRENGTH AND ENERGY (ASTHENIA)	11
22	DEPRESSION	11
23	MENTAL STATUS CHANGES	11
24	DROWSINESS	11
25	MEMORY IMPAIRMENT	10

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LITHIUM CARBONATE Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
180	190	22	392

Medwatch Reporter Type	Count
Consumer	135
Physician	20
Pharmacist	121
Other Health Professional	49

Top Indications

Product used for unknown indication
Mania
Bipolar disorder
Bipolar I disorder

Type of Outcome Reported
Serious: 295
Not Serious: 97
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 392
Concomitant Drugs: 265
Note: A single MedWatch report can list more than one drug. This summary includes LITHIUM CARBONATE identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

LITHIUM CARBONATE (LITHIUM CARBONATE) Rx Drug:
FDA Safety-related Labeling Changes

LITHOBID (LITHIUM CARBONATE) Rx Drug:
FDA Safety-related Labeling Changes

Have experience (good or bad) with LITHOBID? Rate LITHOBID at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.